Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer

Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial

The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.

Inclusion Criteria:

• completely resected pathological stage IB or II NSCLC
• adequate haematological, renal and liver function and condition

Exclusion Criteria:

• previous chemo or radiotherapy for NSCLC
• bronchoalveolar cell subtype
• second active primary malignancy or serious concomitant medical disease
• difficulties with adequate follow-up